Regulatory Publishing

Expert Regulatory Publishing to Support Successful eCTD Submissions

Our regulatory publishing team will support the publishing of your regulatory applications, amendments, supplements and reports to the United States Food and Drug Administration (FDA) through the Electronic Submissions Gateway (ESG).  Currently, the FDA requires most regulatory submissions to be submitted in eCTD format, which improves the efficiency of delivery, formatting, and review of the submission files.

Oversight, Expertise, and Ability to Successfully Publish eSubmissions to the FDA

Due to increasing regulatory agency requirements, Veristat delivers regulatory publishing support as part of our regulatory application solution.  Our clients benefit from having end-to-end services – the same team works on your program from a regulatory, CMC and clinical perspective, writes your regulatory documents, and then submits them through the ESG to the FDA.

Our publishing experts provide:

  • Project and timeline management for the regulatory publishing process
  • Conversion from paper submissions to eCTD format
  • Use of standardized templates
  • Document level publishing
    • Word formatting: styles, captions, cross-references, tables, etc.
    • Conversion of files to required standards
    • PDF processing: bookmarks, internal links, PDF properties, QC
  • Submission level publishing: eCTD placement, cross-document links, study tagging files (STF)
  • Submission quality control (QC)
  • Transmission of submissions to FDA via Electronic Submissions Gateway
  • Archive and document transfer: archival of final word docs and submission sequence
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Publishing Expertise  

Types of Regulatory Applications Published

Our publishing team is ready to publish the following regulatory documents to the FDA:

  • Original Dossiers 
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • Biologics License Application (BLA)
  • All Submission Supporting Documentation
    • Protocol Amendments
    • Investigator Documents
    • Expedited Pathway Submissions
    • Annual Reports, and more
  • DMFs

 

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